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Method of Treating Atherosclerosis, Dyslipidemias and Related Conditions

Inactive Publication Date: 2010-10-14
MERCK SHARP & DOHME CORP
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

[0010]Moreover, the method of treatment described herein can incorporate the administration of a DP receptor antagonist compound, in an amount that is effective to reduce or eliminate the flushing effect that may otherwise occur.
[0011]Further, the method of treatment described herein incorporates the administration of simvastatin in an amount that is effective for treating atherosclerosis or dyslipidemias or for lowering LDL.

Problems solved by technology

This side effect is caused by the nicotinic acid-induced release of prostaglandin D2 in the skin and is so severe that many patients discontinue nicotinic acid treatment.
Reaching therapeutic doses in this manner can take several months, and many patients discontinue treatment during the titration phase due to the flushing effect that is experienced.
Also, historically patients and physicians are not rigorous in maintaining dose titration schedules, and patients often do not reach target doses because of this failure to titrate.

Method used

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  • Method of Treating Atherosclerosis, Dyslipidemias and Related Conditions
  • Method of Treating Atherosclerosis, Dyslipidemias and Related Conditions

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Embodiment Construction

[0012]Niacin or nicotinic acid (pyridine-3-carboxylic acid) is a drug commonly known for its effect in the elevation of high density lipoproteins (HDL) levels, as well as other beneficial alterations of the lipid profile (lowering very low density lipoprotein (VLDL), low density lipoprotein (LDL), triglycerides, free fatty acids (FFA) and lipoprotein(a) [Lp(a)]). Nicotinic acid raises HDL levels when administered to humans in therapeutically effective doses, such as about 500 mg to as high as about 8 grams per day. However, nicotinic acid is frequently associated with cutaneous vasodilation, also called flushing. Flushing typically entails a reddening of the skin, accompanied by warmth, itchiness or irritation. It can be extremely unpleasant, and can be so severe that many patients discontinue nicotinic acid treatment. The present invention relates to the treatment of dyslipidemias and the prevention or reversal of atherosclerosis and the other diseases and conditions described here...

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Abstract

A method of treating atherosclerosis, dyslipidemias and related conditions is disclosed wherein a therapeutic dose of nicotinic acid, approximately 1 gram, is administered to the patient once daily as a starting dose, and the dose is thereafter raised within a few days or weeks to 2 grams for the duration of therapy. The nicotinic acid may be administered in combination with a selective DP receptor antagonist. The selective DP receptor antagonist is administered to reduce, prevent or eliminate flushing that may otherwise occur.

Description

BACKGROUND OF THE INVENTION[0001]Niacin or nicotinic acid (pyridine-3-carboxylic acid) is a drug commonly known for its effect in elevating serum levels of high density lipoproteins (HDL). However, nicotinic acid is frequently associated with cutaneous vasodilation, sometimes called flushing. This side effect is caused by the nicotinic acid-induced release of prostaglandin D2 in the skin and is so severe that many patients discontinue nicotinic acid treatment.[0002]The present invention relates to the treatment of atherosclerosis, dyslipidemias, diabetes and related conditions by administering nicotinic acid in a regimen that achieves therapeutic levels of nicotinic acid rapidly, while reducing or eliminating the cutaneous vasodilation that might otherwise occur, such that treatment can progress to the target dose without substantial flushing. This is achieved in humans by administering nicotinic acid alone or with a compound that antagonizes the DP receptor. Dosing is typically ini...

Claims

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Application Information

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IPC IPC(8): A61K31/455A61P9/10A61K31/437A61K31/538A61K9/24
CPCA61K31/403A61K45/06A61K2300/00A61P3/06A61P9/10
Inventor PAOLINI, JOHN F.LAI, ESENGMITCHEL, YALE B.
Owner MERCK SHARP & DOHME CORP
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